Parkinson DiseasePhase 1/2NCT00159172
Safety and Efficacy of Motor Cortex Stimulation in the Treatment of Advanced Parkinson Disease
A Phase 1/2 study testing Motor cortex stimulation in people with Parkinson Disease, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
The purpose of this study is to determine whether motor cortex stimulation, a mildly invasive surgical procedure, is safe and effective in advanced stage Parkinsonian patients who display side effects with dopaminergic treatment. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Parkinson Disease
- What is being tested?
- Motor cortex stimulation
- Type of treatment
- Medical device
- How many people
- 10 participants
- Where
- 1 siteFrance
- Study dates
- Sep 2005to May 2008
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age between 18 and 70 years
- Idiopathic Parkinson disease, for at least 5 years of evolution
- Asymmetric akinetic-rigid form, with symptoms predominant in the right side of the body (stimulator will be implanted on the left side).
- Functional impairment score in off stage (no drug treatment) of 3-4 according to the Hoehn and Yahr scale
- UPDRS III score > 40 in off-drug stage.
- UPDRS III score with L-dopa treatment improved by at least 50% compared to UPDRS III score in off-drug stage
Who cannot join
- Age superior to 70 years
- Adult patients under guardianship
- Previous neurosurgical operation(s)
- Previous partial or generalised seizures
- Mini Mental Status (MMS) score 24 or Mattis score < 130 or Montgomery-Asberg Depression Rating Scale (MADRS) depression score > 20.
- Presence of signal abnormalities on T1- and T2- MRI sequences
- Abnormalities in general exam or biological constants (hemogram, ionogram, hepatic or kidney dysfunction) with a higher surgical risk
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Neurosurgical Department Henri Mondor Hospital
Créteil, 94100
Yves Kéravel, MD, 33149812201
Philippe Remy, MD, PhD
About this study
Official title: Phase 1 Study of Motor Cortex Stimulation in the Treatment of Advanced Parkinson Disease
The purpose of this study is to determine whether motor cortex stimulation, a mildly invasive surgical procedure, is safe and effective in advanced stage Parkinsonian patients who display side effects with dopaminergic treatment.
Read the detailed description
Advanced stage of Parkinson disease (PD) is a difficult condition to treat, especially after several years of dopaminergic drugs. Recent development of neurosurgical techniques using deep brain stimulation leads has shown good behavioral results in these advanced PD patients. However, the placement of a stimulation lead in the subthalamic nucleus is a complex, invasive, and long surgical procedure. Such intervention requires a sophisticated technical environment, including a stereotactic magnetic resonance imaging (MRI) exam, associated with per-operative electrophysiological exploration of deep brain structures. This surgical treatment can therefore be indicated only for a few selected patients, and cannot be offered to a large proportion of patients among the potential candidates (estimation of 5000 patients in France). Thus, there is a need to develop therapeutic alternatives that would be technically and practically more convenient, less invasive, and that could be offered to a larger number of patients. Several clinical studies, including one led by our group, have already demonstrated that transcranial magnetic cortical stimulation could improve bradykinesia and shorten motor reaction time in patients with Parkinson disease. The clinical benefit was however moderate, and transient, probably because the stimulating sessions were too short in duration.
A prolonged effect could be obtained with continuous cortical stimulation. Such cortical stimulation has already been developed with good clinical tolerance in our hospital since 1991 for chronic neuropathic pain syndromes. In a non-human primate model of late stage Parkinson disease, we have recently demonstrated that prolonged primary motor cortex stimulation significantly improved both akinesia and bradykinesia.
The primary objective of this pilot study will be to evaluate the tolerance and efficacy of chronic stimulation of the primary motor cortex in 10 patients suffering from advanced stage Parkinson disease, despite the optimisation of dopaminergic treatment. The expected benefit for the patient will be gait improvement, increased movement velocities, and finally a better quality of life associated with reduction in dopaminergic medication and low per-operative morbidity risk.
- Conditions
- Parkinson Disease
- Being tested
- Motor cortex stimulation
- Keywords
- Advanced parkinson disease, Stimulation, Motor Cortex, Parkinson disease C10.574.812, Electric Stimulation Therapy E02.831.580.438, Neuronavigation E05.873.249
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Motor cortex stimulationDevice
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety of the treatment and Unified Parkinson Disease Rating Scale (UPDRS) III 1 month following constant stimulation with and without motor cortex stimulation when the patient has no anti-parkinsonian drug for 12 hours
Secondary outcomes (5)
Quality of life: Parkinson's Disease Questionnaire 39 (PDQ39) scores
Anti-parkinsonian drug doses (equivalent L-dopa)
Results of motor activation study in positron emission tomography (PET) scan
Results of the different neuropsychological tests
Video movement analysis
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2005 (estimated)
- Study startSep 2005
- Study completionMay 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Parkinson DiseaseStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Early clinical test
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Enrolment
- 10 participants
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Investigators
- Stephane Palfi, MD, PhD, Principal investigator, Paris 12 University- APHP
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00159172
- Sponsor's protocol ID
- Parkostim
- Status last verified
- Sep 2005
- First submitted
- 7 Sep 2005
- Last updated
- 6 Mar 2007
- Results posted
- No
Publications
Drouot X, Oshino S, Jarraya B, Besret L, Kishima H, Remy P, Dauguet J, Lefaucheur JP, Dolle F, Conde F, Bottlaender M, Peschanski M, Keravel Y, Hantraye P, Palfi S. Functional recovery in a primate model of Parkinson's disease following motor cortex stimulation. Neuron. 2004 Dec 2;44(5):769-78. doi: 10.1016/j.neuron.2004.11.023.
PubMed 15572109
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 1 Study of Motor Cortex Stimulation in the Treatment of Advanced Parkinson Disease
- ClinicalTrials.gov ID
- NCT00159172
- Acronym / sponsor ID
- Parkostim
- Conditions
- Parkinson Disease
- Keywords
- Advanced parkinson disease, Stimulation, Motor Cortex, Parkinson disease C10.574.812, Electric Stimulation Therapy E02.831.580.438, Neuronavigation E05.873.249
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 10 participants
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- Sep 2005
- Study completion
- May 2008
- First posted
- 12 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine whether motor cortex stimulation, a mildly invasive surgical procedure, is safe and effective in advanced stage Parkinsonian patients who display side effects with dopaminergic treatment.
Detailed description
Advanced stage of Parkinson disease (PD) is a difficult condition to treat, especially after several years of dopaminergic drugs. Recent development of neurosurgical techniques using deep brain stimulation leads has shown good behavioral results in these advanced PD patients. However, the placement of a stimulation lead in the subthalamic nucleus is a complex, invasive, and long surgical procedure. Such intervention requires a sophisticated technical environment, including a stereotactic magnetic resonance imaging (MRI) exam, associated with per-operative electrophysiological exploration of deep brain structures. This surgical treatment can therefore be indicated only for a few selected patients, and cannot be offered to a large proportion of patients among the potential candidates (estimation of 5000 patients in France). Thus, there is a need to develop therapeutic alternatives that would be technically and practically more convenient, less invasive, and that could be offered to a larger number of patients. Several clinical studies, including one led by our group, have already demonstrated that transcranial magnetic cortical stimulation could improve bradykinesia and shorten motor reaction time in patients with Parkinson disease. The clinical benefit was however moderate, and transient, probably because the stimulating sessions were too short in duration.
A prolonged effect could be obtained with continuous cortical stimulation. Such cortical stimulation has already been developed with good clinical tolerance in our hospital since 1991 for chronic neuropathic pain syndromes. In a non-human primate model of late stage Parkinson disease, we have recently demonstrated that prolonged primary motor cortex stimulation significantly improved both akinesia and bradykinesia.
The primary objective of this pilot study will be to evaluate the tolerance and efficacy of chronic stimulation of the primary motor cortex in 10 patients suffering from advanced stage Parkinson disease, despite the optimisation of dopaminergic treatment. The expected benefit for the patient will be gait improvement, increased movement velocities, and finally a better quality of life associated with reduction in dopaminergic medication and low per-operative morbidity risk.
Study design
- Primary purpose
- Early clinical test
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age between 18 and 70 years
- Idiopathic Parkinson disease, for at least 5 years of evolution
- Asymmetric akinetic-rigid form, with symptoms predominant in the right side of the body (stimulator will be implanted on the left side).
- Functional impairment score in off stage (no drug treatment) of 3-4 according to the Hoehn and Yahr scale
- UPDRS III score > 40 in off-drug stage.
Key exclusion criteria (7 listed)
- Age superior to 70 years
- Adult patients under guardianship
- Previous neurosurgical operation(s)
- Previous partial or generalised seizures
- Mini Mental Status (MMS) score 24 or Mattis score < 130 or Montgomery-Asberg Depression Rating Scale (MADRS) depression score > 20.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Motor cortex stimulation | Device | – |
Primary outcome
Safety of the treatment and Unified Parkinson Disease Rating Scale (UPDRS) III 1 month following constant stimulation with and without motor cortex stimulation when the patient has no anti-parkinsonian drug for 12 hours
5 secondary outcomes
Quality of life: Parkinson's Disease Questionnaire 39 (PDQ39) scores
Anti-parkinsonian drug doses (equivalent L-dopa)
Results of motor activation study in positron emission tomography (PET) scan
Results of the different neuropsychological tests
Video movement analysis
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2007.
- Background: PubMed 15572109Drouot X, Oshino S, Jarraya B, Besret L, Kishima H, Remy P, Dauguet J, Lefaucheur JP, Dolle F, Conde F, Bottlaender M, Peschanski M, Keravel Y, Hantraye P, Palfi S. Functional recovery in a primate model of Parkinson's disease following motor cortex stimulation. Neuron. 2004 Dec 2;44(5):769-78. doi: 10.1016/j.neuron.2004.11.023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Stephane Palfi, MD, PhD principal investigator
Paris 12 University- APHP
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Motor cortex stimulation in people with Parkinson Disease, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 6 Mar 2007. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Stephane Palfi, MD, PhD (33149812203, stephane.palfi@hmn.aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety of the treatment and Unified Parkinson Disease Rating Scale (UPDRS) III 1 month following constant stimulation with and without motor cortex stimulation when the patient has no anti-parkinsonian drug for 12 hours. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00159172, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Mar 2007.